[Federal Register Volume 66, Number 116 (Friday, June 15, 2001)]
[Rules and Regulations]
[Pages 32539-32540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Ceftiofur Sterile Powder for Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Pharmacia and Upjohn Co. The supplemental 
NADA provides for subcutaneous injection of a solution of reconstituted 
ceftiofur sodium powder in cattle.

DATES: This rule is effective June 15, 2001.

FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary 
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7569.

SUPPLEMENTARY INFORMATION: Pharmacia and Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed supplemental NADA 140-338 that provides 
for use of Naxcel (ceftiofur sodium) sterile powder for 
injection by subcutaneous injection of a solution of reconstituted 
ceftiofur sodium powder in cattle for the treatment of several 
bacterial diseases.

[[Page 32540]]

    Supplemental NADA is approved as of May 29, 2001, and the 
regulations are amended in 21 CFR 522.313 to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this supplemental 
application may be seen in the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning May 29, 2001, 
because the supplement application contains substantial evidence of the 
effectiveness of the drug involved, any studies of animal safety or, in 
the case of food-producing animals, human food safety studies (other 
than bioequivalence or residue studies) required for approval of the 
supplemental application and conducted or sponsored by the applicant.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec. 522.313  [Amended]

    2. Section 522.313 Ceftiofur sodium powder for injection is amended 
in paragraph (d)(1)(i) by adding after ``intramuscularly'' the phrase 
``or subcutaneously''.

    Dated: June 7, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-15083 Filed 6-14-01; 8:45 am]
BILLING CODE 4160-01-S